9 Elements of ConsentContact InformationWho the participants can contact with questionsPrincipal InvestigatorStudent researcher (optional)IRB officeFor international research– a local contact is required

10 Elements of ConsentA statement that participation is voluntary, participants can quit/withdraw at any time and that they can refuse to answer and/or skip any questions they do no wish to answer.

11 The Consent Form WizardThe IRBs strongly recommend that you use the Consent Form Wizard to draft consent documents.

12 Informed ConsentExamples of parental consent, assent for minors and oral consent for those aged 10 and under.

13 Combined Consent and HIPAA AuthorizationHIPAA regulations define health information as “any information, whether oral or recorded in any form or medium that:Is created or received by a health care provider, health plan, public health authority, employer, life insurer, school or university, or healthcare clearinghouse; andRelates to past, present, or future physical or mental health or condition of an individual; health care to an individual; or the past, present, or future payment for the provision of health care to an individual.

14 Combined Consent and HIPAA AuthorizationProtected Health Information (PHI) includes any individually identifiable health information. Identifiable refers not only to data that is explicitly linked to a particular individual. It also includes health information with data items which reasonably could be expected to allow individual identification.

16 Combined Consent and HIPAA AuthorizationIn order to use PHI in a research study, the research participant must grant authorization.The privacy rule authorization can be included in the informed consent document.The authorization must be written in plain language and must included all of the required elements.

17 Combined Consent and HIPAA AuthorizationAuthorization Elements:Description of PHI to be used or disclosed.The name(s) of person(s) authrorized to make the requested use or disclosure.The name(s) of persons who may use the PHI or to whom the covered entity may make the requested disclosure.Description of each purpose of the requested use or disclosure. Researchers should note that this element must be research study specific, not for future unspecified research.

18 Combined Consent and HIPAA AuthorizationAuthorization Elements (Cont.):Authorization expiration date or event that relates to the individual or to the purpose of the use or disclosure (“end of research study” or “none” can be used for research purposes.Signature of individual and date.The individual’s right to revoke the authorization in writing.The potential for the PHI to be re-disclosed by the recipient and no longer protected by the privacy rule

19 Additional Info Exculpatory language Proofread.Double and triple-check to ensure that the details in the protocol application match the details on the consent form.Signed consent forms should be retained for 7 years after the end of the study.